What are the most significant advancements in oral solid dosage (OSD) manufacturing technologies, such as automation, continuous manufacturing, and 3D printing, and how are they shaping the industry in 2025?
Steven Facer, Senior Vice President, Global Sales and Marketing, Adare Pharma Solutions: One of the most significant recent advancements in oral solid dosage manufacturing is the emergence of 3D screen printing - a transformative technology that overcomes the scalability and formulation challenges of earlier 3D printing methods. Traditional laser- and nozzle-based systems have long struggled with high costs, API degradation, and limited production volumes. In contrast, 3D screen printing introduces a scalable, additive manufacturing process that enables precise, layer-by-layer construction of drug formulations.
This approach unlocks the ability to produce multi-functional, multi-compartment tablets and microtablets with highly customized release profiles, whether immediate, extended, sequential, or delayed. This precise control over complex layering and timing mechanisms enhances therapeutic efficacy and makes treatment regimens more patient-centric and convenient.
Crucially, this technology supports a seamless transition from small-scale R&D batches to full-scale commercial production, with capacities reaching up to 1.5 million units per day. It also opens new opportunities for IP protection and product differentiation through unique dosage forms that would be difficult to replicate using conventional methods.
In the years to come, 3D screen printing will play an increasingly large industry role in providing streamlined development and efficient manufacturing for CDMOs and delivering personalized medicine to patients.
John McDermott, Vice President, Scientific Consulting, Quotient Sciences: Oral solid dose manufacturing continues to be a key focus area for our industry, and significant advancements have been made in continuous manufacturing, which we expect to remain a key objective for industry in 2025 and beyond. To fully exploit the benefits of continuous manufacturing over traditional “batch” manufacturing however, larger commercial volumes are necessary. With the increasing industry focus towards rare and orphan diseases, with the associated lower volumes, investment in development and validation of continuous manufacturing may not be justifiable and support from small, agile CDMOs to deliver on batch processes will remain important. Overall, industry will continue to require a balance of technologies to support the ever-changing demands of drug development.
Of course, 3D printing does potentially offer one solution to the small scale, agile conundrum. Quotient has performed a number of evaluations of the technology in our early development manufacturing units. Whilst again there have been some successes here, at the present time minimal “practical use” of 3D printing with large pharma and biotech companies. Whilst its an interesting area, the technology likely requires further exploration before it finds its true application.
Richard Sidwell, Chief Scientific Officer, Bend Bioscience: Advancements in automation have enhanced efficiency and reduced errors and downtime in our tablet and capsule production. Continuous manufacturing remains a niche solution, ideal for specific high-volume products but not yet common because of the cost and complexity of setup. Similarly, 3D printing is promising for personalized medicine but is still limited to specialized applications. We still prioritize traditional batch processing, leveraging automation to optimize quality and throughput, as scalability and cost-effectiveness keep traditional methods dominant for most clients in 2025.
William Wei Lim Chin, Ph.D., Senior Manager, Scientific Marketing, Catalent: The OSD world is moving fast. Along with automation and continuous manufacturing, combining smart delivery formats with powerful manufacturing know-how is reshaping how therapies are developed and delivered. Across the industry, there is a growing need for dosage forms that boost bioavailability, improve patient compliance, and make treatments easier to take. CDMOs such as Catalent are driving the next wave of advancements that will define the future of oral drug delivery. Our Zydis® orally disintegrating tablet (ODT) technology offers a simple, water-free dosing experience, especially for pediatric, geriatric, and dysphagia patients. Our softgel technologies help complex molecules by improving their bioavailability and offering flexible release profiles. We are also expanding what is possible with stick pack technologies. Using advanced dosing systems like auger, slider, microdosing, and minitablet filling, we create flexible, precisely dosed formats for powders, granules, pellets, or liquids. Furthermore, by applying data-driven modeling, including multivariate data analysis, we are able to predict processability early and build scalability from the start.
Gus LaBella, Director of Formulation Development, Mikart: Advancements in oral solid dosage (OSD) manufacturing technologies - particularly automation, continuous manufacturing, and 3D printing - are shaping a more agile and responsive pharmaceutical landscape in 2025. These technologies are improving production speed, consistency, and flexibility, and supporting the development of personalized therapies, high-potency drugs, and more complex dosage forms. Continuous manufacturing, for instance, offers real-time quality monitoring and greater efficiency, while 3D printing enables the creation of customized drug release profiles tailored to individual patient needs.
As the industry embraces these innovations, the emphasis remains on maintaining cGMP compliance, robust quality systems, and flexible development capabilities. Mikart supports this evolution by providing pharmaceutical partners with development-to-commercialization solutions for a wide range of OSD formats. Our technical teams focus on formulation problem-solving and scalable processes to meet the increasingly complex needs of clients, from early development through commercial supply.
These technological shifts signal a future where CDMOs must be adaptable, quality-focused, and ready to integrate emerging practices. Mikart remains committed to this future by investing in strong partnerships, operational excellence, and the expertise necessary to bring innovative therapies to market efficiently and reliably.
How are evolving regulatory requirements, including the FDA's guidance on advanced manufacturing and cGMP compliance, impacting contract manufacturers in the OSD market?
Sidwell: Evolving FDA guidance on advanced manufacturing and cGMP compliance demands continuous attention. The current pace of change at the US federal level is creating uncertainty, straining FDA bandwidth, and slowing initiative rollouts. We find that our investment in, and attention to compliance, ensuring robust quality systems, is attractive to future-focused clients. Current regulatory complexity and uncertainty, not to mention geopolitical and tariff risks, are drawing clients to stable US-based CDMOs like ours. Our high-science, high-service approach helps navigate these challenges, delivering compliant, scalable solutions while mitigating risks.
Lisa Caralli, Senior Director, Scientific Advisory, Catalent: New regulatory requirements for advanced manufacturing have fostered increased collaboration among drug development companies, CDMOs, and regulatory agencies. Organizations such as the non-profit National Institute for Pharmaceutical Technology and Education (NIPTE) play a crucial role in facilitating these partnerships. By bringing these stakeholders together, groups like NIPTE allow subject matter experts to collaboratively evaluate how to meet regulatory requirements. This interaction moves away from the traditional fee-for-service model that typically defines the relationship between CDMOs and drug developers. This collaborative approach also shifts the perceived role of regulatory bodies from mere enforcers to active participants in the innovation process. Creating forums for open communication allows for the rapid implementation of new technologies, ultimately accelerating the delivery of drugs to patients. This paradigm shift not only enhances the efficiency of drug development but also ensures that cutting-edge treatments reach those in need more swiftly.
LaBella: Evolving regulatory requirements, including the FDA's guidance on advanced manufacturing and cGMP (current Good Manufacturing Practice) compliance, are significantly reshaping operations for contract manufacturers in the oral solid dosage (OSD) market. The FDA has been increasingly supportive of modern technologies such as continuous manufacturing and real-time release testing, which require contract manufacturers to adapt their infrastructure, training, and quality systems to meet these new expectations.
For CDMOs, this shift represents both a challenge and an opportunity. Compliance with evolving guidelines demands greater investment in automation, digital quality systems, and robust process controls. However, those who can align early with regulatory expectations gain a competitive advantage - offering clients faster development timelines, improved quality assurance, and greater regulatory confidence.
At Mikart, we stay ahead by embedding cGMP best practices across all phases of development and manufacturing. Our team is trained on the latest regulatory standards, and we work closely with clients to ensure their products meet global compliance from day one. This proactive approach reduces regulatory risk and supports successful product approval and commercialization. As the FDA continues to promote innovation in pharmaceutical manufacturing, CDMOs like Mikart that can nimbly adapt are well positioned to be long-term strategic partners.
What trends are driving the growth of the OSD contract manufacturing market, such as the demand for high-potency drugs, controlled-release formulations, and targeted drug delivery systems?
Facer: A variety of market forces and technological shifts are driving the growth of the OSD contract manufacturing sector in 2025.
Ongoing supply chain disruptions and shifting global trade policies are driving pharmaceutical companies to prioritize regional diversification and supplier agility. CDMOs with strong domestic footprints and flexible sourcing strategies are in high demand.
A growing emphasis on patient-centric dosage forms, especially for special populations like pediatrics and geriatrics. These formulations improve adherence through customized release profiles and alternative formats such as sprinkles, chewables, and ODTs.
The acceleration of digital innovation - from AI to 3D printing - is transforming pharmaceutical development. CDMOs that adopt advanced technologies to streamline processes and enhance precision are becoming key strategic partners.
The increasing complexity of drug therapies requires sophisticated formulation expertise. Many next-generation molecules present solubility, stability, and delivery challenges that demand integrated, platform-based solutions.
Pediatric drug development is increasingly becoming a higher priority within the industry, and CDMOs must navigate its distinct complexities, including customized dosage forms and development strategies aligned with children's unique physiological needs. Success depends on more than just scaling down adult doses; it requires advanced delivery solutions, comprehensive knowledge of pediatric pharmacology, and a commitment to patient-centric design.
McDermott: Controlled-release (CR) formulations can provide an option for a more effective treatment and better patient compliance and offer an ideal life-cycle management solution. Careful development and control of these formulations is necessary to ensure the optimal pharmacokinetic profile is achieved. Traditionally this required two or three cycles for formulating CR prototypes and evaluating their performance before being able to scale up and manufacture supplies for late stage clinical and commercial purposes.
We commonly approach modified release formulation development and clinical testing using a formulation "design space" concept, applied to our Translational Pharmaceutics® platform for integrated drug development. Formulation design space allows a range of formulation compositions to be approved for exploratory clinical evaluation by regulators with limited batch data. Once approved, the development team can make and test any formulation within the design space in our clinical unit in response to emerging PK data. In this way, drug developers can often identify the ideal drug product compositon more quickly, saving a minimum of 12 months, allowing focusing of scale up and drug product supply efforts to only the optimal formulation. This efficiency is driving significant growth in Quotient’s business.
Additionally, we continue to see increased demand for drug products containing HPAPIs. To meet this demand, we’ve made recent renovations to some of our GMP spaces at our Boothwyn, Pennsylvania facility (located near Philadelphia). Converting two rooms allowed for improved handling and containment for drug products with HPAPI up to PBLEC4, increased efficiency and safety, and some added capacity. Later this year, equipment to support PBLEC5 handling will be added.
Sidwell: The OSD market is still growing steadily. We see rising demand for high-potency drugs, especially in oncology, requiring specialized containment facilities. Controlled-release and targeted delivery systems remain critical for optimizing therapeutic outcomes for certain drug candidates and are holding steady. Geopolitical uncertainties and supply chain derisking are fueling reshoring to the US. We excel in solving bioavailability enhancement, controlledrelease challenges, and tech-transfer, aligning with these trends.
Caralli: The rise in new drug candidates within the beyond rule of five (bRo5) space has driven innovation in OSD development and manufacturing. These molecules are uniquely able to target more complex biological structures and are often leveraged to penetrate the “undruggable” small molecule space. Because of their structure, molecules like bifunctional protein degraders often require specialized techniques to enhance their bioavailability by improving solubility and permeability. Additionally, handling protein degraders necessitates higher safety standards. To address these needs, there is a demand for increased capacity to manage potent enabling techniques such as amorphous dispersions and lipid-based formulations. Lipid-based formulations and softgel technology are particularly effective for bRo5 molecules, as they can simultaneously tackle solubility and permeability challenges. Moreover, working with liquids creates a process train that is well-equipped to handle containment issues.
LaBella: The oral solid dosage (OSD) contract manufacturing market continues to grow, driven by several key trends. The increasing demand for high-potency active pharmaceutical ingredients (HPAPIs) is a major factor, as these compounds require specialized containment, equipment, and expertise to ensure safe and compliant manufacturing. Additionally, there is rising interest in controlledrelease formulations and targeted drug delivery systems that can improve patient adherence and therapeutic outcomes. These advanced formulations demand greater technical expertise and flexible manufacturing solutions from CDMOs.
Mikart is well-positioned to support this evolving landscape. We have the infrastructure and experience to handle high-potency compounds safely, as well as the capability to manufacture a range of complex OSD products, including modified-release and multi-particulate formulations. Our formulation development and manufacturing teams work closely with clients to bring innovative therapies to market efficiently while maintaining the highest standards of quality and compliance.
As pharma companies increasingly outsource to streamline operations and access specialized capabilities, CDMOs like Mikart are stepping up to offer not just capacity, but strategic partnership. The convergence of these trends is reshaping the role of contract manufacturers making adaptability, technical depth, and regulatory readiness more important than ever.
How is the integration of digital technologies, such as AI-based monitoring systems and data analytics, improving quality control and efficiency in OSD manufacturing?
Facer: The integration of advanced digital technologies, particularly AI-based systems, is driving significant improvements in efficiency, precision, and agility across OSD manufacturing. With its ability to analyze vast datasets, AI can streamline everything from early-stage formulation design to commercial-scale production by enabling faster, data-driven decision-making.
Rather than adopting new technology for its own sake, though, CDMOs should prioritize innovations that solve real challenges, such as quality control and efficiency. By thoughtfully evaluating the effectiveness of digital tools with a focus on meaningful impact, CDMOs can identify technologies that streamline development and manufacturing timelines, overcome quality challenges, and reduce sponsor pain points.
McDermott: In pharma, AI was first being applied in drug discovery but now being found in almost every function throughout development - method development, report writing, investigation of quality events, manufacturing process control, facility management. AI also has significant potential in support of process development studies in later stage drug product manufacturing, especially through machine learning in driving Quality by Design.
Critical to exploiting the acceleration and process understanding of AI however is ensuring that regulator acceptance of these processes maintains pace with the innovation. Acceleration is key to driving new molecules through to patients and will allow focussing of resources and funding through the development process. However, if deceleration is necessary to “back fill” data sets for regulators then that benefit might not be transferred to the patient.
Sidwell: Digital technologies like AI-based monitoring and data analytics are transforming quality control by enabling things like rapid process feedback and predictive maintenance. We integrate these tools to enhance our understanding of process performance in development and manufacturing. Analytics helps optimize equipment performance, maintenance and calibration schedules, and reduces overhead costs and downtime. These advancements allow us to meet stringent cGMP standards while delivering high-service solutions, giving clients confidence in our ability to maintain quality and accelerate timelines in a competitive market.
Caralli: Data modeling, AI, and machine learning offer exciting opportunities to optimize drug product manufacturing processes. However, before we get to manufacturing drug product, we can use these tools to ensure we are taking the right formulation and dosage form into production. Formulation development often relies on trial and error rather than data-driven methods. This can be improved through the appropriate use of modeling tools. Physiologically-based pharmacokinetic (PBPK) modeling can be leveraged to predict human PK by the intended route of administration for the drug molecule. Additionally, AI-enhanced tools can help select the right combination of excipients predicted to provide the best performance prior to in vivo studies, reducing time and cost. This can be beneficial for more complex formulations systems like those used for lipid-based formulation approaches. When it is time to manufacture drug products, AI will increasingly be used to optimize existing process trains, and those learnings will be implemented into new ones. While CDMOs provide an exciting opportunity to train on a large and complex data set, they will need to work through the legal aspects of data privacy to ensure better products for patients, while ensuring confidentiality to customers.
LaBella: The integration of digital technologies like AI-based monitoring systems and advanced data analytics is significantly enhancing quality control and operational efficiency in oral solid dosage (OSD) manufacturing. AI-driven systems enable real-time monitoring of critical process parameters, allowing for early detection of deviations and faster corrective actions. Predictive analytics help manufacturers anticipate equipment maintenance needs, reducing downtime and improving overall yield. Additionally, digital tools streamline batch record-keeping and regulatory compliance, ensuring greater transparency and traceability.
At Mikart, we recognize the value of these advancements and continue to explore digital solutions that support our commitment to high-quality, efficient manufacturing for our partners.
What challenges do contract development and manufacturing organizations (CDMOs) face in scaling up production while meeting stringent quality standards, and what opportunities exist for innovation and outsourcing?
McDermott: The key question to ask in scaling up production processes is truly understanding how far we actually need to scale. Whilst the big therapeutic areas of oncology, cardiovascular and diabetes still exist, pharma is finding druggable niches in the rare and orphan indication space which will require CDMO support from agile organizations without necessarily needing to drive scale.
Sidwell: The main challenge in production scale-up is ensuring that you have a scalable equipment path suitable to meet future demand for the product. Keeping design and planning for future scale-up an active topic amidst development and clinical supply delivery milestones is key. Opportunities for innovation lie in improved automation, consistent data collection, and process data analytics to further enhance scalability. Choosing a CDMO during early-phase development with future scale in mind makes it easier to meet quality standards consistently as your product progresses. We design for scale from the outset, leveraging our expertise in larger clinical batch manufacturing and commercial production.
Chin: Scaling production while maintaining stringent quality standards has always been a major challenge, particularly as therapies become more complex. As a result of that, outsourcing is evolving from a tactical decision to a strategic partnership. Today, more pharmaceutical companies are turning to outsourcing partners to help manage this complexity, reduce risk, and speed up time-to-market. CDMOs that invest in scalable, adaptable manufacturing technologies, paired with strong development-to-commercialization expertise, are positioned to help innovators confidently scale complex dosage forms while maintaining quality and regulatory compliance.
LaBella: Scaling up production while meeting rigorous quality standards is a core challenge for CDMOs, especially as drug formulations grow more complex. At Mikart, we’re purpose-built to meet these demands with a strong foundation in process development, tech transfer, and commercial-scale manufacturing of oral solid dose (OSD) products. Our integrated teams ensure that quality and compliance are maintained at every stage - from clinical development to full-scale production.
Mikart’s flexible infrastructure supports high-potency compounds, controlled-release formulations, and multi-layer tablets, enabling us to handle a diverse product portfolio with precision. Our robust quality systems and experienced regulatory team help streamline approvals while maintaining cGMP compliance. As outsourcing continues to rise, Mikart stands out by offering not just capacity, but a true partnership - delivering reliable scale-up, responsive communication, and technical excellence that accelerates our clients' path to market.
How are manufacturers addressing patient preferences for user-friendly dosage forms and designs, particularly with advancements in oral biologics and obesity treatments?
Facer: In today’s market, patient preferences for user-friendly dosage forms are a key driver of pharmaceutical innovation. For many patients, adherence remains a persistent challenge due to factors like difficulty swallowing, unpleasant taste, and complicated dosing regimens. To address these issues, manufacturers are turning to patient-centric dosage forms that prioritize convenience, flexibility, and adherence.
The development of oral alternatives to traditionally injectable drugs is gaining momentum as manufacturers seek to improve patient compliance and broaden access to treatment. Converting injectables to oral formulations, however, presents significant challenges, including poor solubility, low bioavailability, and degradation in the gastrointestinal tract. Overcoming these hurdles demands advanced drug delivery technologies and a high level of technical sophistication.
As patient-centricity becomes a cornerstone of healthcare delivery, CDMOs who innovate with user-friendly designs will not only improve adherence but also differentiate their products in a competitive marketplace.
McDermott: Today’s molecules are frequently difficult to formulate for preferred delivery routes, such as oral administration. User friendliness however is crucial in development of novel therapeutics as it is the patient who is our ultimate customer, and pharma and manufacturers recognize this. Developing the oral formulation remains a challenge though, especially as traditional formulation development pathways will generally assess bioavailability in animal models before assessment in humans. Such animal models are often not predictive of human performance which can misdirect the development program and lead to formulation failure.
A good example would be the oral formulation of peptide drugs which are often assessed in dog models, resulting in significant excitement about bioavailability that does not translate into humans.
Quotient has significant experience in developing oral peptide formulations to overcome permeability challenges using our Translational Pharmaceutics platform to accelerate the evaluation of formulation prototypes using human data to avoid misleading data consuming development time.
We’ve also invested in our physiologically based pharmacokinetic (PBPK) modeling and simulation expertise is this area. We worked with a Fortune 50 pharma client to redevelop a peptide from a subcutaneous (SC) formulation to OSD. This aimed to simplify administration over weekly injections for greater patient access and compliance. SNAC was used in this case as a permeation enhancing excipient. Understanding the fluctuating compositions of both the peptide and the permeation enhancer and being able to make predictions of potential in-vivo performance was essential. Our team developed a bespoke PBPK model to describe both the peptide and the permeation enhancer, allowing prediction of potential formulations for clinical evaluation. The combination of PBPK modelling and clinical data emerging from our Translational Pharmaceutics platform allowed for continuous model refinement to improve accuracy of predictions. Ultimately, we were able to better explain and predict the permeation process within a specific range, and the model used by our M&S team has set a novel approach for future work.
Sidwell: Patient preference for user-friendly dosage forms drives innovation, particularly for discretionary medications like obesity treatments, as seen with GLP-1 drugs. We focus on designing user-friendly tablets and capsules, optimizing size, taste, and ease of administration. While oral biologics are emerging, bioavailability is still a key challenge. A focus on the science of bioavailability enhancement offers the hope of maintaining therapeutic effect with reduced dosage strength. This saves money and reduces patient dosing burden. Our high-science, high-service approach ensures close collaboration with clients to align product design with patient-centric goals.
Caralli: Recent advances in nanoparticle design and the successful oral delivery of GLP-1 peptide agonists have spurred increased exploration of complex drug modalities, such as proteins and RNA, in routes traditionally reserved for small molecules. This shift requires collaboration and cross-education among scientific staff and manufacturing operators to ensure a mutual understanding of the unique attributes and degradation pathways of these drug modalities, preventing product degradation during the manufacturing process. Issues such as API hygroscopicity, susceptibility to enzymes and proteases, and adsorptive loss are critical considerations when working with these molecules. While many manufacturing techniques used for small molecules can be applied to large molecules, it is crucial to be mindful of degradation pathways and physical stability conformational attributes specific to large molecules. Therefore, establishing a manufacturing partnership that integrates both oral solid manufacturing expertise and the analytical and process expertise for large molecules is essential. Success in this field requires a synergistic approach, as one cannot thrive without the other.
LaBella: Patient-centric drug design is increasingly important in today’s pharmaceutical landscape, particularly with the rise of oral biologics and therapies for chronic conditions like obesity. Manufacturers are responding by developing user-friendly dosage forms that improve adherence, reduce dosing frequency, and enhance the overall patient experience. This includes innovations such as taste-masked formulations, multi-particulate systems, and modified-release tablets that offer more convenient and controlled delivery.
At Mikart, we’ve aligned our development and manufacturing capabilities to support these trends. Our expertise in oral solid dose (OSD) formulations including layered tablets, granules, and powders allows us to address complex delivery requirements while maintaining patient-friendly characteristics like swallowability and dosing precision. For obesity and metabolic treatments, where patient compliance is critical, we help clients develop formulations that balance efficacy with ease of use.
By combining formulation science, process flexibility, and a focus on patient needs, Mikart plays a key role in helping pharmaceutical companies deliver therapies that meet today’s expectations for convenience, safety, and performance.
What is the projected growth trajectory of the global OSD contract manufacturing market through 2030, and which regions or segments are expected to dominate?
Facer: The global OSD contract manufacturing market is on a strong growth trajectory, driven by increasing demand for complex formulations, patient-friendly dosage forms, and flexible development solutions. As pharmaceutical companies continue to outsource more of their manufacturing needs, CDMOs with advanced technologies and proven expertise are well positioned to capture market share.
Geographically, growth is expected across all major regions, but North America and Europe will continue to remain key markets, thanks to their established industry presence and focus on innovation and quality standards. Asia-Pacific is emerging as a particularly strong player as well due to its expanding pharmaceutical infrastructure and cost advantages.
Tablets will continue to dominate, but there’s rising interest in more adaptable formats like capsules and multiparticulates, especially as patient-centricity becomes a priority.
The OSD contract manufacturing space is evolving quickly, and CDMOs that can offer agility, technical depth, and tailored solutions will be best equipped to lead in the years ahead.
Sidwell: We expect high single-digit growth for the global OSD contract manufacturing market through 2030. Specific trends, such as re-onshoring to the US, are likely to be driven by geopolitical and tariff uncertainties. Bioavailability enhancement, high-potency drugs, and controlled-release formulations will remain key segments. We expect the US to dominate as companies seek to derisk their supply chains and secure their access to the world’s largest market.
Chin: The global OSD contract manufacturing market is projected to grow steadily through 2030, driven by the continued strength of small molecules and the emerging opportunity of oral biologics. Recent data show that most new drug approvals from 2020 to 2024 were next-in-class molecules, with first-in-class therapies accounting for about one-third.1 This trend highlights the enduring role of small molecules in the global pharmaceutical pipeline, especially for oncology, metabolic disease, and rare disorders, where oral delivery remains the preferred route for patient convenience and adherence. At the same time, advances in formulation science are making oral delivery of biologics increasingly viable. Techniques such as permeability enhancement and enzyme protection are helping to overcome traditional barriers to delivering peptides, proteins, and RNA-based therapies through the gastrointestinal tract.
LaBella: The global oral solid dosage (OSD) contract manufacturing market is projected to experience steady growth through 2030, driven by rising demand for tablets and capsules, especially in chronic disease treatment and emerging therapeutic areas. Industry analysts estimate a compound annual growth rate (CAGR) of approximately 5 - 6%, with the market surpassing $50 billion globally by the end of the decade.
North America is expected to maintain a strong foothold due to advanced manufacturing infrastructure and regulatory rigor, while Asia-Pacific is projected to see the fastest growth, fueled by cost advantages, increasing pharmaceutical consumption, and expanding CDMO capabilities. High-potency APIs (HPAPIs), modified-release formulations, and fixed-dose combinations are expected to be the most dynamic product segments.
For CDMOs like Mikart, this trajectory reinforces the need for technical agility, robust quality systems, and capacity to scale. Our strategic U.S.-based operations and long-standing expertise in OSD manufacturing position us to support clients navigating this expanding landscape - offering reliable capacity, speed-to-market, and specialized services tailored to evolving market and regional demands.
Author Details
Steven Facer, Senior Vice President, Global Sales and Marketing, Adare Pharma Solutions
John McDermott, Vice President, Scientific Consulting, Quotient Sciences
Richard Sidwell, Chief Scientific Officer, Bend Bioscience
William Wei Lim Chin, PhD, Senior Manager, Scientific Marketing, Catalent
Gus LaBella, Director of Formulation Development, Mikart
Lisa Caralli, Senior Director, Scientific Advisory, Catalent
Publication Details
This article appeared in Pharmaceutical Outsourcing:Vol. 26, No.2 Apr/May/June 2025Pages: 20-28